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THE OFFICE OF RESEARCH
RESEARCH INVESTIGATOR HANDBOOK
5. BEING RESPONSIBLE
5.3 CONFIDENTIALITY AND PRIVACY
• What types of confidential information would I see as PI?
• Are there any special requirements for collaborations?
• What are my responsibilities?
• What Does HIPAA have to do With My Research?
• Relevant Policies and Procedures
What types
of confidential information would I see as PI?
As a Principal Investigator, you may be asked
to review grant proposals, scientific manuscripts, academic reviews
of your colleagues. You may also see confidential records of
your staff or collect human subjects data.
All of these activities require that you protect
names, unpublished data, concepts, private and personal information
that may affect
publication, intellectual property rights, reputation and privacy.
Research activities that require your protection of confidential
information include:
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Peer Review: |
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Proposal Review |
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Protocol Review |
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Manuscript Review |
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Confidential academic reviews |
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Human subjects research: |
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Case Report Forms |
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Research records in any format |
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Verbal information provided by subject |
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Medical Records |
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Staff records: |
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Staff employment records |
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Staff protected health information |
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Are there
any special requirements for collaborations?
For collaborations involving industry, partnerships
and other contracts, confidentiality is usually specified in
the terms and conditions of the contract negotiated by the Office
of Sponsored Research or Office of Technology Management. Discretion
is expected with respect to disclosing information that may affect
future patents and licensing agreements.
For other types of collaborations, you should work out in advance
with your collaborators what types of information may be made
public before publication.
What
are my responsibilities?
As UCSF faculty, you are expected to practice
discretion and maintain the highest level of confidentiality
in all aspects of your research. You are expected to comply with
all Federal regulations, State laws, and University
of California directives to protect the privacy of individuals. This includes
staff, UCSF personnel, your colleagues, human research participants
and anyone with whom you may have access to confidential information.
What Does HIPAA have to do With My Research?
The Health Information Portability and Accountability Act (HIPAA), April 14, 2003, specifically mandated that all identifiable health information must be protected from inappropriate or unauthorized disclosure. This information is referred to as “protected health information” (PHI) and is specifically defined by HIPAA for institutions as well as researchers. Recent regulations such as SB 1386, AB 1298, and the 2009 Health Information Technology for Economic and Clinical Health Act require notification to affected individual if their unsecured or unencrypted electronic personal or health records are breached. The fines could be significant.
As a researcher, HIPAA
applies to both medical and basic research, as you must protect
all staff, patient, and human subjects information that you may
collect as part of your research. As a member of the UCSF workforce,
HIPAA applies to all PHI regardless of it’s whether it
for a staff member, faculty, research fellows, students, or UCSF
patients. As a researcher, you need to consider physical security of all such data and encryption for all laptops and portable electronic data storage devices in your department.
Specific guidance, forms, and training for UCSF is posted at
the following websites:
Relevant
Policies and Procedures
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